Experienced and flexible, Tox Clarity supports your team at any scale – from providing a discrete second opinion to leading a comprehensive nonclinical program.
Tox Clarity advances the nonclinical development of your drug in four arenas.
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Strategy
Build road maps for the nonclinical development of new drug products
- Enable first-in-man clinical studies through marketing authorization
- Optimize opportunities for streamlined programs and study waivers
- Coordinate multi-year scientific programs to support go/ no-go business decisions
- Characterize small molecules and biologics
- Niche expertise in dermatologic, ophthalmic, and hematologic indications
- Develop realistic timelines and budgets
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Empirical Study
Design scientific assessments to meet regulatory objectives
- Enable INDs and NDAs/BLAs with toxicology studies conducted in accordance with FDA and ICH Guidances, Good Laboratory Practices, and industry standards
- Address clinical hold concerns
- Meet post-marketing committments
Manage wet-lab experiments at external toxicology laboratories
- Guide CROs through critical, time-sensitive decision-making to achieve regulatory goals
- Coordinate a cohesive program, interpreting all findings against the same standards and principles to discern the data throughline
- Structure multi-year scientific programs to support clinical timelines
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Submissions & Representation
Contextualize scientific findings in integrated toxicology assessments for Regulatory submissions to the US FDA, Health Canada, and the EMA
- Compose nonclinical sections of IND/CTA/IMPDs, NDA/NDS/MAAs, IBs, CAC communications, safety informational amendments, waiver requests, meeting requests, briefing books, and package inserts
- Define margins of safety to enable risk/benefit analysis
Position Nonclinical in meetings with Regulatory Agencies
- Achieve pre-IND/CTA, EOP2, pre-NDA/NDS, and Type A and C Guidance meeting goals
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Due Diligence
Conduct nonclinical due diligence for product acquisitions
- Identify program gaps
- Project budgets and timelines for advancement
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